A Public Health Framework for Legalized Retail Marijuana...

A Public Health Framework for Legalized Retail Marijuana:Avoiding a New Tobacco Industry

Stanton A.Glantz, PhDProfessor of MedicineDirector, Center for Tobacco Control Research & Education

9/20/2017

The Irony

Tobacco is legal, socially unacceptable, and use is fallingMarijuana is illegal, socially sanctioned, and use is increasingSo, we want to treat marijuana like tobacco

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Cannabis as Medicine

9/20/2017Regulating Medical Cannabis Manufacturing4

Evidence Condition

Conclusive/Substantial Chronic painChemotherapy-induced nausea and vomitingMultiple sclerosis spasticity (patient-reported)

Moderate Sleep disturbance (various etiologies)

Limited HIV/AIDS-associated weight lossMultiple sclerosis spasticity (clinician-measured)Tourette syndromeAnxiety symptomsPosttraumatic stress disorderTraumatic brain injury or intracranial hemorrhage outcomes

Source: National Academies of Sciences, Engineering, and Medicine (2017). The Health Effects of Cannabis and Cannabinoids: The Current State of Evidence and Recommendations for Research. Washington, DC, The National Academies Press.

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Presentation Notes

In 2009, CalEPA conducted an extensive literature review to find that

11/13/2017Presentation Title and/or Sub Brand Name Here6

Cannabis-Tobacco Policy Overlap

Addiction

Adolescent use and initiationAdvertisingCardiovascular & respiratory risksCancerCorporate influence and dominanceCo-use and dual use

Environmental impactFlavorsPackaging/labelingSmokefree environmentsSocial norms keyVapingAnd more…

Just a few examples:


Marijuana as a rival product

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Cannabis in California

Decriminalization – civil offense (1975)• Reduced to infraction in (2010)Medical legalization (1996 voter initiative)

• Supplemented by legislation (2003 and 2015)• Patchwork of local rules Adult use legalization (2016 voter initiative)MAUCRSA (2017)


Cannabis in California: MAUCRSA

Three agencies regulate medical and adult use• Bureau of Cannabis Control‒Lead agency‒ Retailers; distributors; testing labs; microbusinesses

• Department of Public Health‒ Manufactured cannabis products‒Packaging and labeling

• Department of Food and Agriculture‒ Cultivation‒Track and trace

Significant local control


Cannabis Products

12

Also


All images: Leafly. “Products.” https://www.leafly.com/products. Accessed Sept. 1, 2017.

https://www.leafly.com/products

Manufactured Cannabis Products

Definition• Processed or transformed into more concentrated form‒Commonly using butane, CO2, or alcohol

• Consumed directly (e.g., “dabs,” extracts, tinctures)• Combined with other ingredients (e.g., edibles, topicals)Potency

• Can be very high THC (over 80%) in concentrates‒Smoked cannabis current maximum ~30% THC (and a lot lost),

more often 10-20%‒Can be very low THC, high CBD‒Some not psychoactive at all (most topicals)

Method of consumption effect, duration, onset (e.g., edibles)


Public health framework

Legal but discouragedIndustry as disease vectorPubic health engagement with policymaking processMarijuana prevention and control program for general population

• Hard-hitting mass media education campaigns• Comprehensive smokefree and other public usage laws• Tax revenue for prevention and control program and research • Strict marketing and advertising restrictions• Plain packaging and state of art graphic warning labels (not current

US)

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Warning labels

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MarijuanaWashington Colorado


Nevada

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and California

“The involvement of organizations or individuals with commercial or vested interests in the tobacco industry in public health policies with respect to tobacco control is most likely to have a negative effect… [Governments] should not allow any person employed by the tobacco industry or any entity working to further its interests to be a member of any government body, committee or advisory group that sets or implements tobacco control or public health policy.”

Protecting the Policy Process

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Protecting PM process.

Advisory Committee Membership

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In CO, AK, and in CA’s initiative, marijuana industry reps sit on advisory committees to create and guide implementation of the law. For example in CO we found that the advisory committee that established the regulatory framework for retail marijuana consisted of members in the MJ industry, a member of the initiative campaign, and member from alcohol industry. Advisory committees should contain only public health officials or academics, as is the case with TEROC in CA. In 2014, Colorado allowed industry representation on its Amendment 64 Implementation Task Force to “coordinate and propose a regulatory framework” for retail marijuana. More specifically the “Regulatory Framework Working Group” contained several members with conflicts of interest to guide regulations on product design, labeling, and packaging reqts that did not effectively protect public health. Calls involving children nearly doubled to 45 in Colorado involving children 8 or under.

Advisory Committee Membership

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Exclusively members are academics in public health or in public education

State Marijuana Prevention

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None of the states that have legalized retail marijuana provide funding to comprehensive marijuana prevention and control programs aimed at the general public and modeled on evidence-based demand reduction programs for tobacco control WA State Department of Health launched its marijuana prevention and control campaign, designed to educate parents on how to talk to their teens about marijuana use.

Tobacco Industry

Talk. They’ll Listen

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Presentation Notes

Experience from tobacco control demonstrates that dedicating taxes to solely youth-based and school-based programs Is not the most effective way to prevent initiation or minimize use and may have counteractive effects. Boomerang effects Tobacco companies have promoted these programs for years RJRs “Right Decisions Right Now” PMs “Youth smoking prevention program” saying “Talk. They’ll Listen.”

Tobacco Control

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Put in ads from Calif, FDA, TIPS, Truth

California: Where we are today

Draft rules for medical market issued in April 2017• Withdrawn because of MAUCRSAGive idea of things to come

• Prop 64 requires agencies to begin licensing by January 2018Updated rules will be issued on an emergency basis

• Will take effect immediately, followed by public comment & revision • Not usual process of public comment and revision first Problems with draft rules

• Poor labeling standards• High potency limits for manufactured cannabis products• 8 ounce daily sale limit for medical cannabis much higher than

anywhere else, typically 1 ounce a day or less• Allows law enforcement agents to be in cannabis business

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Undermines California Smokefree Laws and Norms

• MAUCRSA allows ‒Smoking, vaping, ingesting in cannabis retailer or microbusiness if age restricted, cannabis not visible from public place, no sale

or consumption of alcohol or tobacco on premises.‒Beer garden style temporary event cannabis consumption at

county fairs or agricultural events if consumers admitted are 21+ and the local jurisdiction allows

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Labeling: Text Only Static Warnings

• SCHEDULE I CONTROLLED SUBSTANCE• KEEP OUT OF REACH OF CHILDREN AND ANIMALS• FOR MEDICAL USE ONLY• IF PREGNANT OR BREASTFEEDING, CONSULT A PHYSICIAN

PRIOR TO USE• THE INTOXICATING EFFECTS OF THIS PRODUCT MAY BE

DELAYED BY UP TO TWO HOURS• THIS PRODUCT MAY IMPAIR THE ABILITY TO DRIVE OR

OPERATE MACHINERY, PLEASE USE EXTREME CAUTION


Labeling

Minimum .5” x .5” size• Regardless of package sizePrinted “legibly and conspicuously”

• Vague industry manipulation

CA proposed regulation (§ 40412): universal cannabis product symbol


Labeling

Colors• Black = most visually prominent color• Yellow = most effective for gaining and keeping consumer

attention, less attractive, signals warning• Black + Yellow = danger (e.g., road warnings)Size

• No direct tobacco control analogue• 20% primary panel based on graphic warnings

Better: Adopt a highly visible and salient cannabis product symbol


Packaging: Abusive Industry TacticsCA Proposed Regulation (§ 40410(c)(2)-(c)): prohibits packaging with “[c]artoons; [a]nylikeness to images, characters, or phrases that are popularly used to advertise to children; or [a]ny imitation of candy packaging or labeling”


Sources: Chong, O. “Cannabis Companies Need to Stop Stealing Intellectual Property.” New Cannabis Ventures. Jan. 3, 2017. https://www.newcannabisventures.com/cannabis-companies-need-to-stop-stealing-intellectual-property/. http:/analytical360.com/m/dope-cup-2015/383415/ , https://www.cannabisreports.com/edible-reports/baked-goods/weetos-crunchy

Should: Eliminate all packaging that appeals to children or imitates any non-cannabis product

https://www.newcannabisventures.com/cannabis-companies-need-to-stop-stealing-intellectual-property/

Plain packaging for all cannabis products

Common for restricted-access medical products (e.g., prescription drugs)Effective for tobacco productsGeneric labeling and packaging already an option in Oregon

• Avoid preapproval requirement and fee


Source: http://www.tobaccolabels.ca/plain-packaging/Source: https://openclipart.org/detail/190009/prescription-bottle-and-pills

Source: http://www.oregon.gov/olcc/marijuana/Documents/Packaging_Labeling/ChecklistandGeneric.pdf

http://www.tobaccolabels.ca/plain-packaging/

https://openclipart.org/detail/190009/prescription-bottle-and-pills

http://www.oregon.gov/olcc/marijuana/Documents/Packaging_Labeling/ChecklistandGeneric.pdf

How Uruguay is doing it


Government monopoly on salesOnly 2 (low-THC) varieties of product available, and only dried flowerPrivate companies providing the cannabis not permitted to brand packaging

Source: http://www.telenoche.com.uy/politica/uruguay-se-convirtio-en-el-laboratorio-del-mundo.html

http://www.telenoche.com.uy/politica/uruguay-se-convirtio-en-el-laboratorio-del-mundo.html

Products: Prohibit Harmful Formulations


CA proposed regulation (§ 40300(b)): prohibits use of additives in cannabis products “that would increase potency, toxicity or addictive potential” “Include but are not limited to nicotine and caffeine”

• Ambiguity: all forms? (e.g., powdered vs. coffee vs. chocolate)

BETTER: Prohibit ALL additives that promote addictiveness or initiation, including all nicotine, caffeine, menthol, and characterizing flavors

http://www.businessinsider.com/buying-pure-caffeine-powder-off-the-internet-2015-9

Why prohibit harmful formulations


Makes it hard to design more appealing, dangerous products to increase consumptionProhibit menthol as an additive

• Local anesthetic effect‒ Likely same for inhaled cannabis

• Conditioned reinforcer for nicotine due to sensory effects‒Similar effect for cannabis likely (but untested)

• Menthol cigarette smokers more likely to use cannabisProhibit all characterizing flavors

• Known youth appeal for tobacco products, junk food• Likely same for cannabis

Products: Prohibit Harmful Formulations


CA proposed regulation (§ 40306): limits all nonedible manufactured medical cannabis products to 1000mg THC per unit• Too highNon-cannabis topical products are an existing poisoning concern

• Most cannabis topicals are non-psychoactive on skin, but ingestion is another matter

• Medical cannabis topicals may resemble commonly encountered products (e.g., lotions or balms)

• Some look like food (e.g., honey oil) or trade on appeal of food-like flavors‒ “Pineapple Dream Concentrate”

http://www.dopemagazine.com/review-pineapple-dream-concentrate/

Why California Matters

History• Epicenter of counterculture movement in 1960s• First medical legalization stateProduction

• “Emerald Triangle” – Humboldt, Mendocino, Trinity CountiesSize and influence

• Largest medical legalization jurisdiction in U.S• Will be largest adult use jurisdiction globally• Projected 868,000 medical users (currently 1.5M) • Projected 4.4M total users in 2018


Conclusions

Absent strong regulation, marijuana industry will increasingly resemble tobacco industry• Marketing, product engineering, PR, and political influence to

maximize profits Need strong product regulation

• Attendant health burdenLarge graphic warnings, rotating warning language, and plain packagingProtect nonusers, smokefree environmentsPublic education modeled on California Tobacco Control ProgramTaxation to discourage useStrong conflict of interest lawsBusiness interests dominating the policymaking process, by defaultOnce bad policies are put in place, difficult to change Health groups have been silent


Acknowledgement

Daniel Orenstein, JD MPH

Candice Bowling, JD MPP

Some of the material in this presentation is work I have done in collaboration with my postdoctoral fellows.


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